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Expanding the vididencel opportunity

In the second quarter of 2025, Mendus reported data from the pivotal Phase 2a ADVANCE II trial at different keynote conferences, confirming that its lead product vididencel acts an active immunotherapy across different subtypes of high-risk acute myeloid leukemia (AML). Expansion of the vididencel clinical development in AML is ongoing, with the CADENCE Phase 2b combination trial actively recruiting patients in Australia.

Mendus reported positive data from the Phase 1 ALISON trial in ovarian cancer at ASCO, demonstrating tumor-directed immune responses that are associated with improved progression-free survival, and secured a US patent for use of vididencel in this indication. Mendus remains committed to the execution of a clinical trial strategy focused on market registration of vididencel as a post-remission therapy in (AML), combined with a broadening of the addressable patient population in AML and potentially other myeloid malignancies, with chronic myeloid leukemia (CML) as a prioritized indication. The company has maintained an active dialogue with the pharmaceutical industry to ensure that the next steps in the clinical development of vididencel match medical need and industry expectations.

 

Erik Manting, CEO

In May, Mendus announced the appointment of Dr Tariq Mughal as Chief Medical Officer to strengthen the company’s late-stage development capabilities. With his extensive expertise in hematology, oncology and pharmaceutical industry R&D, Tariq brings scientific rigor and deep under­standing of market demands, combined with a global academic and industry network. Early fall 2025, we plan to provide a detailed update of our clinical trial strategy to cap­ture the opportunity in AML and to open up CML as a potential new vididencel indication.

Expansion of the vididencel clinical development in AML led to the randomized Phase 2b AMLM22-CADENCE trial, in collaboration with the Australasian Leukaemia and Lymphoma Group. In the trial, vididencel is combined with oral azacitidine to treat AML patients in first complete hematological remission, irrespective of the measurable residual disease (MRD) status. Recruitment is ongoing and update of the status and outlook of the CADENCE trial in the context of the vididencel development strategy will be included during the strategy update later this year.

Additional data from the ADVANCE II trial were presented in May at the Cancer Immunotherapy Conference (CIMT) and during the annual meeting of the European Hematology Association (EHA) in June. The data presented at CIMT showed that the T cell repertoire to control residual disease improved following vididencel treatment, whereas the data presented at EHA confirmed that vididencel acts indepen­dent of specific AML mutations. These findings support the broad positioning of vididencel as a post-remission therapy to control residual disease and prolong disease-free survival across different subtypes of AML.

To scale up the manufacturing for further clinical develop­ment and future commercial supply of vididencel, Mendus has entered a manufacturing alliance with NorthX Biologics. The alliance is on track to deliver clinical-grade material in the second half of 2025, which represents an important milestone on the path to late-stage development and market registration of vididencel.

In its earlier-stage pipeline, Mendus realized substantial progress in the ovarian cancer program. Data from the Phase 1 ALISON trial which studies vididencel as an active immunotherapy for the treatment of high-grade serous ovarian cancer patients were presented at the annual meeting of the American Society for Clinical Oncology (ASCO) in June. The data presented demonstrate the successful induction of tumor-directed immune responses following vididencel treatment, which were associated with improved progres­sion-free survival. Long-term follow-up will help us better understand the potential of vididencel as a treatment for women diagnosed with this hard-to-treat life-threatening malignancy. The next read-out of the ALISON trial based on 2-year follow-up is anticipated in the fourth quarter of 2025.

In July, we received notice that the United States Patent and Trademark Office granted a patent covering the use of vididencel in ovarian cancer, further validating vididencel’s potential in ovarian cancer following the positive clinical data presented at ASCO.

Based on the proof-of-concept data in AML, combined with a validated and focused strategy, Mendus is in a strong position to capture the vididencel opportunity in AML and other myeloid malignancies. We look forward to providing a detailed strategy update in early fall and thank our stake­holders for their continued support.

Erik Manting, Ph.D.
Chief Executive Officer

 

*Published on August 21, 2025